Combination Drugs

Any drug before being permitted for marketing in the country for the first time undergoes a series of scientific studies— pre-clinical studies or animal model studies and clinical (human) trials carried out in three phases. It is also important to monitor adverse drug reaction after the drug is allowed to be marketed. The requirements of safety and efficacy are the same if one or more drugs have to be combined together as a dosage form. In other words the fixed dose...

PARIS: Sanofi said on Wednesday a first late-stage Phase III study of its LixiLan diabetes drug had met its main target, while another would be completed at the end of the third quarter. LixiLan consists of a single-injection combination of Lyxumia, a drug developed with Danish drugmaker Zealand Pharma , and Sanofi's Lantus. It targets patients suffering from type 2 diabetes. The first study tested the efficacy and safety of LixiLan versus treatment with either...

NEW DELHI: Pharma firms need to explain the medical rationale for combination drugs while seeking marketing approval for them, an expert panel set up by the government has recommended. This move is intended to get rid of irrational combination drugs which have flooded the domestic market today. Combination drugs comprise over 46% of the 70,000-crore domestic drug market . Drugmakers would have to show why an ingredient needs to be combined with...

NEW DELHI: The government may give permission to 44 more combination drugs ? a formulation of two or more active ingredients combined in certain fixed doses - for treating diarrhoea, fever, pain and hypertension, said a health ministry official. Known as fixed dose combination (FDC) drugs in pharmaceutical industry parlance, these will help reducing the number of pills in a single dosage, and consequently the expenses incurred. For instance, doctors usually prescribe...

NEW DELHI: Flooded with over 5,000 combination drug applications awaiting clearance, the central drug regulator has set up an expert panel under president of the Pharmacy Council of India , B Suresh , to fix standard parameters, which would be used to isolate unsafe combination drugs from the safe ones. This committee would be a subcommittee under the Drug Technical Advisory Board, the apex body for regulation for technical matters on drug safety. Combination drugs...

NEW DELHI: Puducherry-based drugmaker GuruFcure has come under the Drug Controller General of India's scanner for allegedly submitting fabricated data while seeking approval for manufacturing seven fixed dose combination drugs. "The investigative team concluded that all the data submitted (by the contract manufacturer in case of the seven combination drugs) is fabricated and not authentic," the central drug regulator...

NEW DELHI: The upcoming drug pricing policy may deter manufacturers from continuing to lace their essential lifesaving drugs with supplements such as vitamin C or D or increasing their potency just to escape the mandated price caps. According to an official familiar with the policy in the works, the government is likely to mandate that companies planning to launch new combination drugs with essential medicines as an ingredient may have to do so at a price equal...

NEW DELHI: The government's efforts to weed out 'potentially unsafe' combination drugs for which pharma companies have not taken the central drug regulator's permission by September 30 has run into a wall. The High Court of Himachal Pradesh on September 27 granted an interim stay on Drug Controller General of India's (DCGI's) directive of July which intended to dub all those combination drugs as 'illegal' for...

NEW DELHI: Flooded with over 5,000 combination drug applications awaiting clearance, the central drug regulator has set up an expert panel under president of the Pharmacy Council of India , B Suresh , to fix standard parameters, which would be used to isolate unsafe combination drugs from the safe ones. This committee would be a subcommittee under the Drug Technical Advisory Board, the apex body for regulation for technical matters on drug...

AHMEDABAD: The Rs 500-crore Indian homoeopathy pharma market will see its future growth coming from combination drugs. The rising demand for safe alternative medicine that has no side effects is leading to the growing demand in the segment. As a result, Indian companies are aggressively chasing the combination drug market, creating their own research-based combination and getting it patented. Most of the combination drugs are OTC products used for treatment of joint...

The Global Fund to fight AIDS, tuberculosis and malaria has welcomed America's announcement of plans to speed review and approvals for fixed-dose combination AIDS drugs. The Geneva-based global public-private partnership dedicated to attracting and disbursing additional resources to prevent these diseases has said the availability of these medications will help facilitate its efforts to scale up AIDS treatment in more than 100 developing nations. The United States announced on...

NEW DELHI: The government's efforts to weed out 'potentially unsafe' combination drugs for which pharma companies have not taken the central drug regulator's permission by September 30 has run into a wall. The High Court of Himachal Pradesh on September 27 granted an interim stay on Drug Controller General of India's (DCGI's) directive of July which intended to dub all those combination drugs as 'illegal' for which drugmakers have...

NEW DELHI: Pharma firms need to explain the medical rationale for combination drugs while seeking marketing approval for them, an expert panel set up by the government has recommended. This move is intended to get rid of irrational combination drugs which have flooded the domestic market today. Combination drugs comprise over 46% of the 70,000-crore domestic drug market . Drugmakers would have to show why an ingredient needs to...

NEW DELHI: Drug firm Strides Arcolab today said it has received tentative approval from the US health regulator for anti-AIDS combination drug. The company has received the approval from the United States Food and Drug Administration for its abbreviated new drug application (ANDA) for Tenofovir Disoproxil Fumarate and Emtricitabine tablets in the strengths of 300 mg and 200 mg, Strides Arcolab said in a statement. "The company is one among the 6 generics...

NEW DELHI: The upcoming drug pricing policy may deter manufacturers from continuing to lace their essential lifesaving drugs with supplements such as vitamin C or D or increasing their potency just to escape the mandated price caps. According to an official familiar with the policy in the works, the government is likely to mandate that companies planning to launch new combination drugs with essential medicines as an ingredient may have to do so at a price...

MUMBAI: The government's attempts to keep a lid on drug price increases may not work as its failure to change rules in line with radical changes in drug discovery may keep several commonly-used medicines out of price control. Drug industry executives, activists and health care experts say that the changes in the Drug Price Control Order (DPCO) may not achieve much as the restrictions apply only on drugs made out of a single chemical compound . ...

KOLKATA: Europe's largest pharma company Sanofi-Aventis has decided to shore up its diabetes business in India. The company has started research to launch India-specific combination drugs and plans to roll out its blockbuster insulin 'Apidra' in India by the year end. It may also look at the option to make India a global manufacturing hub for insulin. Its Indian arm, Aventis Pharma, is the third largest player in both oral diabetes drug and insulin segment. It enjoys around 7.9% market...

NEW DELHI: The controversial fixed dose combination (FDC) drugs issue may soon see an end. Drug companies and the government have formed separate technical committees to jointly decide which of the 294 combination drugs can be phased out and how many can remain in the market. A series of discussions may be held next week. Confederation of Indian Pharmaceutical Industry (CIPI) has agreed to voluntarily stop manufacturing and selling 11 drugs which the...

NEW DELHI: This month, Ranbaxy Laboratories will launch the country's first indigenously developed new medicine, a malaria drug , at one-third the cost of the current therapies. The launch of this drug will end a 15-year drug discovery drought for Indian medicine makers. Indian firms have mastered the art of developing generic versions of original drugs, but success has eluded them in their new drug development efforts which began...

NEW DELHI: The country's drug price regulator has reduced prices of eight medicines sold by leading pharma companies such as Cipla, Sun Pharma and Unichem by up to 85%, in one of the sharpest price cuts over the past few years. The National Pharmaceutical Pricing Authority (NPPA), a few days ago, slashed the maximum price at which these eight medicines could be sold after its market survey found that companies were selling them at a huge...